Medication info
Sitagliptin Tablet 25mg (Sitagliptin Hydrochloride Monohydrate)

Sitagliptin Tablet 25mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.34mg / 1 tablet
Manufacturer / importer
(주)티디에스팜
Appearance
Bright yellow-orange round film-coated tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle
Approval status
Active

MFDS item code 202301860 · Approved 2023.06.19 · Insurance code 679802250

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered once daily at a dose of 100mg for monotherapy or combination therapy, with a maximum daily dose of 100mg. It may be taken regardless of meals. In patients with moderate renal impairment (glomerular filtration rate 30-45ml/min/1.73㎡), a dose of 50mg is administered once daily. Patients with severe renal impairment (glomerular filtration rate 15-30ml/min/1.73㎡) or those requiring hemodialysis or peritoneal dialysis should receive a dose of 25mg once daily.

Ingredients

Manufacturer
(주)티디에스팜

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

  • Type 2 diabetes
  • difficulty controlling blood sugar
View approved original text

This medication is used in conjunction with dietary and exercise strategies to assist patients with type 2 diabetes in controlling their blood sugar levels. It can be administered alone when starting treatment for the first time. If there has been no prior experience with diabetes treatment and blood sugar is not well controlled with monotherapy, it may be used in conjunction with metformin. Additionally, it is combined when blood sugar control is insufficient with monotherapy of sulfonylureas, metformin, thiazolidinediones, or insulin. This medication can enhance therapeutic effects even when blood sugar control remains challenging despite multiple drugs. Thus, it improves blood sugar control in patients with type 2 diabetes across various conditions.

How to take

Adult dose

This medication is administered once daily at a dose of 100mg for monotherapy or combination therapy, with a maximum daily dose of 100mg. It may be taken regardless of meals. In patients with moderate renal impairment (glomerular filtration rate 30-45ml/min/1.73㎡), a dose of 50mg is administered once daily. Patients with severe renal impairment (glomerular filtration rate 15-30ml/min/1.73㎡) or those requiring hemodialysis or peritoneal dialysis should receive a dose of 25mg once daily.

Precautions

This medication may cause severe allergic reactions after administration; if symptoms such as skin rash or difficulty breathing occur, discontinue use immediately and consult a physician. During the use of this medication, serious pancreatic inflammation (acute pancreatitis) may occur; thus, any symptoms such as abdominal pain or vomiting should be reported to medical personnel immediately. Patients with type 1 diabetes or diabetic ketoacidosis should not use this medication; it should also be avoided in individuals with allergies to this drug or its components. Patients with impaired kidney function must have their dosage adjusted for this medication, so those with renal disease should consult their healthcare provider. In clinical trials, patients taking this medication primarily reported side effects such as upper respiratory tract infections, headaches, nasopharyngitis, and diarrhea, while the risk of hypoglycemia may increase, particularly when used in combination with insulin or sulfonylureas. This medication can cause symptoms of hypoglycemia when taken with other antidiabetic agents, thus dose adjustments may be necessary when taken with insulin or sulfonylureas. Severe joint pain or blistering skin diseases may occur; if these symptoms appear, inform your physician immediately and stop taking the medication. This medication generally has fewer interactions with certain drugs, but caution is needed when taken with cyclosporine or digoxin, and monitoring by medical personnel is required. Pregnant or breastfeeding women are advised not to take this medication, and its use in patients under 18 years of age should be avoided due to the lack of established safety and efficacy. Elderly patients may have reduced kidney function, thus regular kidney function tests are important before and after taking this medication. In cases of overdose, unabsorbed medication should be removed, and clinical monitoring including cardiac condition should be performed; if necessary, some medications can be removed through hemodialysis.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), tightness in the chest, shortness of breath, anaphylaxis, Stevens-Johnson syndrome, severe skin reactions, acute pancreatitis, severe allergic reactions, acute renal failure, joint pain accompanied by severe symptoms and disability, bullous pemphigoid, liver abnormalities (elevated liver enzymes, jaundice), severe neurological symptoms, severe edema accompanied by hypertension, cardiac arrest

Mild side effects

  • Hypoglycemia
  • upper respiratory infections
  • nasopharyngitis
  • headache
  • abdominal pain
  • nausea
  • diarrhea
  • constipation
  • vomiting
  • myalgia
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  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased serum triglycerides
  • elevated low-density lipoprotein
  • hyperglycemia
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture exposure, ideally at room temperature between 1°C and 30°C. This helps maintain its effectiveness and ensures safe use.

Appearance and packaging

Appearance

Bright yellow-orange round film-coated tablet

Package unit

Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.